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U.S. Department of Health and Human Services

Class 2 Device Recall Lifeline ECG

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  Class 2 Device Recall Lifeline ECG see related information
Date Initiated by Firm April 27, 2020
Create Date June 17, 2020
Recall Status1 Terminated 3 on January 08, 2021
Recall Number Z-2394-2020
Recall Event ID 85702
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product DDU-2450 Lifeline ECG

Model Numbers DDU-A2450EN
DDU-E2450DE
DDU-E2450EN
DDU-E2450FR
DDU-E2450TH

Cat. No. DCF-A2460EN
DCF-A2463EN
DCF-E2460DE
DCF-E2460EN
DCF-E2460FR
DCF-E2460TH

UDI 00815098020287,
00815098020317
Automated External Defibrillators (AED) are indicated for use on victims of sudden cardiac arrest (SCA) who are: - unconscious and unresponsive, not breathing or not breathing normally.
Code Information Serial numbers: 400101347 400101348 400101350 400101351 400101364 400101365 400101368 400101371 400101373 400101380 400101381 400101382 400101384 400101385 400101390 400101392 400101395 400101396 400101398 400101399 400101400 400101401 400101402 400101403 400101404 400101405 400101406 400101407 400101408 400101409 400101410 400101411 400101412 400101413 400101414 400101415 400101418 400101419 400101420 400101421 400101422 400101423 400101424 400101425 400101427 400101428 400101429 400101430 400101431 400101432 400101433 400101434 400101435 400101436 400101437 400101438 400101439 400101441 400101442 400101444 400101446 400101447 400101448 400101449 400101451 400101452 400101453 400101454 400101455 400101456 400101457 400101458 400101459 400101460 400101461 400101462 400101463 400101464 400101465 400101466 400101467 400101468 400101469 400101470 400101471 400101472 400101473 400101474 400101475 400101477 400101478 400101480 400101483 400101486 
Recalling Firm/
Manufacturer		 Defibtech, LLC
741 Boston Post Rd
Suite 201
Guilford CT 06437-2714
For Additional Information Contact Defibtech Customer Service
203-453-6654 Ext. 2
Manufacturer Reason
for Recall		 A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an affected device to fail to delivery shock, and/or to fail to deliver shock in range.
FDA Determined
Cause 2		 Component design/selection
Action The firm contacted affected customers via email and mailed letter on April 27, 2020. Distributors were asked to forward letters to end users. Customers were informed that affected products may abort a shock delivery or reset unexpectedly. Customers were asked to return all affected products for screening. Actions to be taken by the Customer/User: 1. If you have additional AEDs on hand , please quarantine and return any affected units as identified in the Attachment for screening or replacement. Do not include the pads and battery packs when you return your unit. 2. If no other AEDs are available, please continue using the device with caution until a loaner or replacement is provided. 3. Ensure that all users of the AED are informed of the product issue. Defibtech will provide support for handling all aspects of the return of identified units for screening. The firm will contact customers to help them with the process. If you have questions now, please contact the firm using the email address FA2020@defibtech.com. Additionally, Defibtech Customer Support is available by calling 1-877-453-4507, 8:30 A.M. to 5:30 P.M. (Eastern), Monday - Friday.
Quantity in Commerce 860
Distribution Worldwide distribution - US Nationwide distribution and the countries of Australia, Canada, France, Malaysia, Mauritius, Netherlands, Thailand, United Arab Emirates.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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